Status:
UNKNOWN
6-Methyl-Prednisolone for Multiple Organ Dysfunction Syndrome
Lead Sponsor:
Hospital Universitario Principe de Asturias
Collaborating Sponsors:
Pfizer
Conditions:
Multiple Organ Dysfunction Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Background: Systemic corticosteroids are considered in patients with an adverse clinical course suffering from conditions like the acute respiratory distress syndrome (ARDS) and septic shock. Treated ...
Detailed Description
Background: Worldwide intensive care physicians consider administering systemic corticosteroids in patients with an adverse clinical course suffering from conditions like the acute respiratory distre...
Eligibility Criteria
Inclusion
- Main
- Patients with established, unresolving, refractory MODS, in whom all reversible and treatable causes of persistent MODS have been treated or ruled out:
- Patients under endotracheal intubation and mechanical ventilation for at least 7 days.
- Aggregate Multiple Organ Dysfunction Score (5) of greater than 8 over the first seven days of mechanical ventilation and greater than 5 on the day of inclusion.
- Written informed consent to participate in the trial signed by next of kin or other authorized person.
- Additional
- Main cause or disease at admission: Adequate "source control" is required and refers to optimal, complete, and definitive surgical and/or medical therapy.
- Infections:
- Infectious causes of persistence of MODS have reasonably been ruled out on clinical or other grounds (infectious endocarditis, undrained abscesses like sinusitis, empyema or abdominal pus). Consider sampling for culture of broncho-alveolar lavage fluid, protected specimen brush or other (empyema fluid, lung tissue) in order to rule out respiratory infection, as well as intra-vascular catheter change and culture.
- Present or previous infections, either documented or strongly suspected, have been treated for at least 3 days before inclusion.
- Supportive Care: Optimal hemodynamic, renal, hematologic, nutritional "supportive care" is provided.
Exclusion
- Decision not to provide full support.
- Immune status and steroid therapy.
- Steroid therapy
- Currently indicated for chronic or concurrent disease (meningitis, auto-immune disease, asthma, acute exacerbation of chronic obstructive pulmonary disease \[COPD\], or other). Inhaled steroids are allowed.
- Administered during current admission (\> 20 mg/day of 6-methyl-prednisolone or equivalent for \>48 hours).
- Chronic steroid therapy prior to current admission (\> 20 mg of 6-methyl-prednisolone or equivalent/day for \> 1 month during previous 3 months).
- Other immune-suppressive therapy within the previous 6 months.
- Known AIDS.
- Neutropenia \< 500/mcl.
- Preceding organ transplantation.
- Irreversible and or ultimately fatal clinical conditions like metastatic malignant disease or cardiogenic shock caused by coronary artery disease.
- Presence of invasive fungal infection
- Other significant pre-existing underlying chronic diseases:
- Severe parenchymal liver disease (Child-Pugh grade C)
- Severe and irreversible acute or chronic central nervous system disease.
- Severe end-stage chronic obstructive pulmonary disease (home oxygen or more than 1 exacerbation in previous year)
- End-stage renal disease (Chronic dialysis).
- Age less than 18 years.
- Pregnancy.
- Morbid obesity: body mass index above 40.
- Recent (last 3 months) upper gastrointestinal \[GI\] hemorrhage.
- Extensive burns (\>30% body surface area \[BSA\])
- Known allergy to steroids.
- Written informed consent not available.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2008
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00127985
Start Date
August 1 2005
End Date
July 1 2008
Last Update
May 13 2008
Active Locations (6)
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1
Hospital Clinic
Barcelona, Barcelona, Spain
2
Hospital Principe de Asturias
Alcalá de Henares, Madrid, Spain, 28805
3
Hospital Universitario de la Princesa
Madrid, Madrid, Spain, 28006
4
Francisco Ortuño Anderiz
Madrid, Madrid, Spain, 28040